Capital Projects Engineer

Celltrion Inc; Branchburg Township (NJ); Hybrid; USD 87,000 - 172,000; Full time

Benefits offered by this job

Paid Time Off

Medical, Dental, and Vision Insurance

Company-matched Retirement Savings Plan

Wellness Programs

Job summary

A leading biotechnology firm in New Jersey is seeking a Project Manager to oversee capital and expense projects at its Branchburg facilities. The role includes managing engineering projects, ensuring safety and compliance, and leading cross-functional teams. Candidates should possess a B.S. in Engineering and have 3-5 years of project management experience in the pharmaceutical or biotechnology industry. This exempt, salaried position offers hybrid work flexibility and a comprehensive benefits package including medical, dental, and retirement savings.

Qualifications

• Minimum three to five years of experience in project management within the pharmaceutical/biotechnology industry.
• Experience working in a GMP environment is preferred.
• Strong written and verbal communication skills essential.

Responsibilities

• Oversee engineering projects from initiation through completion.
• Lead cross-functional project teams ensuring safety and adherence to timelines.
• Manage project scope and cost controls, and prepare capital requests.

Skills

Project Management

Communication Skills

GMP Knowledge

Team Leadership

Construction Safety Practices

Education

B.S. Engineering or related field

Tools

Microsoft Project

SAP

Job description

This position is responsible for project delivery of capital or expense projects for the existing Celltrion Branchburg, LLC Facilities. Duties of this position include overseeing engineering projects and upgrades to the existing facilities, systems, and equipment. Junior levels within this role may also support senior Project Managers. Projects can involve direct and no impact equipment and systems or GMP and non-GMP facilities in the following areas: architectural renovation and construction; mechanical systems such as utilities and HVAC; process equipment; automation systems such as building management or monitoring systems; electrical systems; laboratory equipment; IT/IDS equipment; and life safety systems among others.

Responsibilities of this position include assembling and leading a team through all aspects of a project lifecycle including initiation and planning; design; construction and installation; commissioning and qualification (known as verification); mechanical and technical completion; and turnover to end user. This also includes aspects that span project delivery including HSE management, project schedule, project change management, and project financials (estimation, capital requests, forecasts, capitalization, cost controls, etc.).

This role owns or is otherwise responsible for the following: initial project scoping and cost estimation, safety planning, project schedule, resource identification (including contracted resources), contractor management, capital requests and capitalization, and project cost/schedule controls. Depending on project size or available Celltrion Branchburg resources, the PM may work with Procurement to contract various roles (i.e. design, automation programming, construction management, verification, etc.). In limited cases, the PM may also act as SME for systems where no SME has been identified. This role also drives on-schedule and on-budget execution of deliverables that they do not directly own such as user requirements development, design reviews, safety reviews, change controls (Q, HS, and/or E), operational readiness, etc.

Manage for Results /Strategic Planning:

• Ensure safety is built into the project from design through completion. Involve HSE representatives to provide user requirements and other input on various health, safety, and environmental aspects of project design, installation, and ongoing operation of systems and equipment.
• Work with project requestor, SME, and other stakeholders to determine project intent and scope including development of user requirements.
• Request for Proposal (RFP) or Request for Quotation (RFQ) development – prepare design or construction/installation RFP/RFQ based on defined scope of work following financial responsibility requirements.
• Develop capital requests for partial or full funding to deliver all aspects of project deliveries. Capital requests will be supported by quotes for materials or services provided. Complete capitalization at end of project upon invoice completion and placing the system in service.
• Develop and own project schedule through all phases of project delivery through system release. Support operational readiness activities, as needed.
• Manage the design process to ensure all project team members participate to define the requirements for a given project.
• Confirm a change control is approved for projects with quality and/or HSE compliance aspects prior to starting construction/ installation. For projects without quality compliance aspects, confirm other change management processes are being followed (i.e. automation changes, IT changes, etc.). Own changes, as required, or provide input or documentation, as needed, in support of change owners,
• Manage team of contractors to deliver scope of work as defined in design and/or specification documentation. Monitor progress versus schedule. Responsibilities also include developing and delivering logistics and communications plans, as necessary. Coordinate shutdowns activities with system or area owners. Own project controls processes for schedule and cost.
• Work with SME and commissioning and qualification personnel to successfully execute and document startup through system release requirements. Monitor progress versus schedule. For smaller projects, the PM may self-perform verification activities.
• Leadership of multiple engineering projects simultaneously with respect to buildings and grounds, equipment and systems for existing manufacturing, processing, laboratory, office and associated support facilities. Projects will range in size from approximately $10K to $5M. The position may also provide support for larger corporate engineering projects with values above $5M.
• Consultation and collaboration with SME in plant/process/automation to ensure technical requirements are met, project requirements are understood, and delivery timelines are established.
• Preparation of capital project approval documentation. Coordination of capital project tracking with Finance Department.
• Preparation of construction, equipment, and service bid packages. Coordination of bids and bid tabulation with the Procurement department.
• Perform construction management to ensure that projects are completed safely, on schedule and within established budgetary goals. For larger projects employing a construction management or general contractor, provide oversight to ensure work is occurring safely, on schedule, and in compliance with all applicable HSE and quality standards and programs.
• Acts a Subject Matter Expert on preparation of capital project approval documentation and process.

ManageRelationships with Key Stakeholders and Customers:

• Project Manager will interact with SME, system user/owner, HSE, QA, QC, Facilities/Utilities, Validation, IT/IDS, design consultants and construction contractors.

Basic Requirements:

• B.S. Engineering, Chemical, Mechanical, Electrical or other related engineering discipline required.
• Minimum three to five years of experience in project management and three to five years of experience managing projects in pharmaceutical/biotechnology industry.
• Experience working in a GMP environment preferred.
• Experience working with contracting firms and managing contractors.
• Experience with capital project execution.
• Strong written and verbal communication skills.
• Experience utilizing Microsoft Project or other project scheduling software.
• Experience and working knowledge of construction site safety practices and procedures and with construction of new building facilities and/or retrofitting of systems.
• Ability to work as a team leader to execute multi-disciplined projects.
• Strong organizational skills.

Additional Preferences:

• Working knowledge of SAP is a plus.
• CAPM or PMP certification is a plus.

This is an exempt, salaried role with an anticipated compensation range of $87,000 – $172,000.

Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability coverage.

The position does not require travel; it may require on-call availability and could involve shift work. Hybrid work flexibility is available based on business needs; relocation assistance is not provided.

Celltrion is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.